Endoluminal prosthetic conduit systems and method of coupling

ABSTRACT

A modular prosthetic conduit system such as a stent or stent graft system tailored for the repair of aneurysms or other compromised vessel walls. The stent or stent graft system incorporates various means to interlock the multiple modular components used in the repair procedure. The present invention further provides a modular stent graft system tailored for the repair of aneurysms or other compromised vessel walls that cross or are adjacent to a branch or bifurcation in a vessel.

FIELD OF THE INVENTION

The present invention relates to endoluminal prosthetic conduit systemsand in particular to methods and components for joining togetherendoluminal prosthetic conduit components.

BACKGROUND OF THE INVENTION

Stents or stent grafts are forms of transluminal prosthetic componentswhich are used to maintain, open or dilate stenotic lesions in bodylumens or to cover and repair an aneurysm. It is often the case that ananeurysm occurs at a branch or bifurcation in a vessel. To repair suchan aneurysm using modular components, one current technique is toinitially deploy across the aneurysm a main body stent or stent grafthaving a side wall opening. The side wall opening is aligned with theside branch ostium. A second stent or stent graft is then deployedthrough the main body stent side wall opening and into the side branchvessel. This modular repair approach requires the modular components tobe effectively sealed at their connection points to prevent bloodleakage into the aneurysm. In addition the modular components must belocked or joined together to prevent subsequent relative displacement ofthe modular components. Similar requirements apply to those proceduresthat use multiple stent grafts that are coupled together to increase theeffective length of the repair device.

SUMMARY OF THE INVENTION

The present invention provides modular prosthetic conduit systems suchas stent or stent graft systems. The modular prosthetic conduit systemsmay be tailored for the repair of aneurysms or for the repair ofcompromised vessel walls. The systems incorporate various embodimentsfor the secure interlocking of the multiple modular components used in avessel repair procedure.

An aspect of the invention includes a prosthetic conduit systemcomprising: an expandable main conduit having a first open end, a secondopen end, a main conduit wall extending therebetween, an outer conduitsurface, and an inner conduit surface having at least one protuberancethereon; an expandable secondary conduit having a first open end, asecond open end, a secondary conduit wall extending therebetween, and anattachment portion extending at an angle of less than 90 degrees fromthe secondary conduit wall when in a deployed state; and wherein atleast a portion of the secondary conduit is sized to fit inside the mainconduit.

A further aspect of the invention includes a prosthetic conduit systemcomprising: an expandable main conduit having a first open end, a secondopen end, a main conduit wall extending therebetween, at least oneopening through the main conduit wall, and an internal channel having aninner surface, an outer surface, a first open end located within themain conduit and a second open end at the opening in the main conduitwall; an expandable secondary conduit having a first open end, a secondopen end, a secondary conduit wall extending therebetween, and anattachment portion extending at an angle of less than 90 degrees fromthe secondary conduit wall when in a deployed state; and wherein atleast a portion of the secondary conduit is sized to fit inside theinternal channel and through the opening in the main conduit wall.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a main conduit with an interconnected secondaryconduit as implanted across an aortic aneurysm.

FIG. 2 is a perspective view of a main conduit having an internalprotuberance.

FIG. 3 is a cross-sectional view of a main conduit having an internalprotuberance.

FIG. 4 is a perspective view of a main conduit joined to a secondaryconduit.

FIGS. 5A and 5B are perspective and side views of a secondary conduithaving an attachment portion. Shown is a defined angle between anattachment portion and a secondary conduit longitudinal axis orsecondary conduit wall.

FIG. 6 is a cross-sectional view of a main conduit having an internalprotuberance that is discontinuous or segmented.

FIG. 7 is a cross-sectional view of a main conduit having an internalprotuberance that incorporates stiffening support structures.

FIG. 8 is a cross-sectional view of a main conduit having an internalstent or support structure with barbs or hooks configured to engage asecondary conduit.

FIGS. 9A and 9B are cross-sectional views of a main conduit havinginternal barbs or internal hooks configured to engage a secondaryconduit.

FIGS. 10A and 10B are perspective views of a secondary conduit havingexternal barbs or external hooks configured to engage a main conduit.

FIG. 11 is a perspective view of a secondary conduit having an externalcuff that is configured to engage and lock onto an open end of a supportchannel.

FIG. 12 is a cross-sectional view of a main conduit having two opposedcuffs.

FIG. 13 is a side view of a secondary conduit having two opposed cuffs.

FIG. 14 is a perspective view of a main conduit and an interconnectedsecondary conduit.

FIGS. 15 A and 15B are side views of main conduits according to certainaspects of the invention.

FIGS. 16 A and 16B are side views of main conduits and secondaryconduits according to certain aspects of the invention.

DETAILED DESCRIPTION OF THE INVENTION

A better understanding of the invention will be had with reference tothe several figures.

Shown in FIG. 1 is a main conduit 20 having a first open end 22 and asecond open end 24. A secondary conduit 26 is shown inserted into thesecond open end 24 of the main conduit 20. The secondary conduit 26 isshown as a bifurcated endoluminal device bridging an aortic aneurysm 28.The main conduit 20 and the secondary conduit 26 are expanded and sharean engagement portion or engagement length 30. In an aspect of theinvention the main conduit 20 and the secondary conduit 26 can beself-expanding or balloon expandable.

A main conduit can have various configurations including stent graftswith or without side-branches or side-branch openings. Stent grafts canbe fabricated, for example, according to the methods and materials asgenerally disclosed in U.S. Pat. Nos. 6,042,605; 6,361,637; and6,520,986 all to Martin et al. Details relating to the fabrication andmaterials used for a main conduit with an internal side branch supporttube or channel can be found in, for example, U.S. Pat. No. 6,645,242 toQuinn.

The main conduit comprises at least one protuberance on the innersurface of the main conduit. Protuberances according to an aspect of theinvention can be in many forms. For example, shown in FIG. 2 is aperspective view of a main conduit 20 having a first open end 22 and asecond open end 24. Internal to the main conduit is protuberance in theform of cuff 32 on the inner surface of the main conduit.

FIG. 3 is a cross-sectional view of a main conduit 20 as viewed alongthe cross-sectional plane 3 of FIG. 2. Shown is a section of a mainconduit 20, first and second open ends 22, 24 and protuberance 32. Theprotuberance 32 is in the form of a cuff 34 that is configured to engagean attachment portion of a secondary conduit. A protuberance or cuff canhave various configurations and can be fabricated, for example, fromtubes, sheets or films formed into tubular shapes, woven or knittedfibers or ribbons or combinations thereof. Protuberance or cuffmaterials can include conventional medical grade materials such asnylon, polyester, polyethylene, polypropylene, polytetrafluoroethylene,polyvinylchloride, polyurethane and elastomeric organosilicon polymers.A protuberance or cuff can be joined to a graft or stent wall bysutures, medical grade adhesives or thermoplastics or can be integral tothe graft or stent wall.

Shown in FIG. 4 is a main conduit 20 having a first open end 22 and asecond open end 24 and a wall 25 extending between the two open ends.The wall defines an outer conduit surface 21 and an inner conduitsurface 23. A secondary conduit 26 is shown inserted into the secondopen end 24 of the main conduit 20. The secondary conduit 26 has a firstopen end 27 a second open end 29 and a wall 31 extending between the twoopen ends. The secondary conduit 26 has an attachment portion 36 shownin a deployed state as flared apices of a stent support structure. Theattachment portion 36 is shown engaged into the protuberance 32 of mainconduit 20. The flared apices of the stent support are therefore engagedand interlocked into the cuff 34, preventing or inhibiting the secondaryconduit 26 from dislodging toward the direction indicated by arrow 38.An improved sealing surface between the secondary and the main conduitsmay also be provided by the protuberance 32. Forces exerted by the flowof blood may encourage or drive the flared apices of the stent supportinto contact with or full engagement with the cuff 34.

Shown in FIG. 5A is a secondary conduit 26 having open ends 27 and 29, awall 31 extending from open end 27 to open end 29, a longitudinal axis40 and an attachment portion 36 shown in an unconstrained or deployedstate as flared-out apices of a support stent. The inner surface 42 ofthe attachment portion 36 defines axis 44. An angle 46 is shown betweenthe secondary conduit longitudinal axis 40 (and the wall 31) and theattachment portion axis 44. Shown is an angle of about 45°. Angle 46 canbe any angle less than about 90°. For example angle 46 can be just lessthan 90°, about 80°, about 70°, about 60°, about 45°, about 30°, about20° or less.

Similar to FIG. 5A, shown in FIG. 5B is a secondary conduit 26 havingopen ends 27 and 29, a wall 31 extending from open end 27 to open end29, a longitudinal axis 40 and an attachment portion 36 shown in adeployed state as flared-out apices of a support stent. The innersurface 42 of the attachment portion 36 defines axis 44. An angle 46′ isshown between the secondary conduit wall 31 and the attachment portionaxis 44. Shown is an angle of about 45°.

Various alternate configurations of attachment portions and/orprotuberances are possible. For example the protuberance 32 can bediscontinuous, forming discrete protuberance segments along the innerwall of a main conduit. A main conduit can have two, three, four or fiveor more discrete protuberance segments, spaced along the inner wall.Shown in FIG. 6 is a cross-sectional view of a main conduit 20 as viewedalong the cross-sectional plane 3 as defined in FIG. 2. Shown is asection of a main conduit 20, first and second open ends 22, 24 anddiscontinuous protuberances 34. The protuberances 34 form a series ofcuffs that are configured to engage attachment portions of a secondaryconduit, such as depicted in FIG. 4.

To assist in the engagement of an attachment portion, a protuberance canincorporate semi-rigid or densified segments along its length. Suchsemi-rigid sections along a protuberance may prevent or inhibit theprotuberance from collapsing. Shown in FIG. 7 is a cross-sectional viewof a main conduit 20 as viewed along the cross-sectional plane 3 asdefined in FIG. 2. Shown is a section of a main conduit 20, first andsecond open ends 22, 24 and a protuberance, shown as cuff 34. Densifiedor semi-rigid sections 62 are incorporated into the protuberance to addrigidity to cuff 34 and thus inhibiting or even preventing the cuff fromcollapsing. Semi-rigid sections 62 can be incorporated into segmented ordiscontinuous protuberances as previously described in FIG. 6.

Semi-rigid or densified segments may be formed from conventional medicalgrade materials such as nylon, polyacrylamide, polycarbonate,polyethylene, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, elastomeric organosilicon polymers; metals such asstainless steels, cobalt-chromium alloys and nitinol and biologicallyderived materials such as pericardium and collagen. Semi-rigid ordensified segments can also comprise bioresorbable materials such aspoly(amino acids), poly(anhydrides), poly(caprolactones),poly(lactic/glycolic acid) polymers, poly(hydroxybutyrates) andpoly(orthoesters).

The at least one protuberance of the main conduit may comprise aninternal stent or support structure that incorporates barbs, hooks orother suitable configurations to engage and/or lock with a secondaryconduit. Shown in FIG. 8 is a cross-sectional view of a main conduit 20as viewed along the cross-sectional plane 3 of FIG. 2. Shown is asection of a main conduit 20, first and second open ends 22, 24 and aninternal stent or support structure 64. Protruding out of the stent orsupport structure 64 are a series of barbs or hooks 66. The barbs orhooks are oriented inwards toward the center of the main conduit and areconfigured to engage and/or lock onto a wall or attachment portion of asecondary conduit.

A main conduit may have a series of internal, barbs or hooks that areintegral to the main conduit wall or integral to a main conduit supportstent. For example if the main conduit has a stent support structure,portions of the stent can be formed into hooks or barbs that areconfigured to engage and lock a secondary conduit. Shown in FIG. 9A is across-sectional view of a main conduit 20 as viewed along thecross-sectional plane 3 of FIG. 2. Shown is a section of a main conduit20, first and second open ends 22, 24 and a series of internal barbs 68.Similarly shown in FIG. 9B are a series of internal hooks 70. The barbsor hooks are oriented inwards toward the center of the main conduit andare configured to engage and/or lock onto an external wall of asecondary conduit. Barbs or hooks may be formed from conventionalmedical grade materials such as those listed above.

Secondary conduits can also incorporate various forms of attachmentportions to engage and/or lock onto main conduits. For example shown inFIG. 10A is a perspective view of a secondary conduit 26 having firstand second open ends 27, 29 and a wall 31. Protruding outwardly awayfrom the secondary conduit wall 31 are a series of external barbs 72.Similarly, shown in FIG. 10B are a series of external hooks 74. Thebarbs or hooks are oriented outwardly away from the center of thesecondary conduit and are configured to engage and lock onto an internalwall and/or protuberance of a main conduit.

A secondary conduit may also incorporate an external cuff that isconfigured to engage a main body protuberance or an open end of aninternal channel. For example shown in FIG. 11 is a perspective view ofa secondary conduit 26 having first and second open ends 27, 29 and awall 31. Formed about the first open end 27 is an external cuff 76configured to engage an internal protuberance or a first open end of aninternal channel of a main conduit. The external cuff may incorporatesemi-rigid sections as shown in FIG. 7 to add rigidity to the cuff.

A main conduit may have opposed anchoring cuffs that prevent a secondaryconduit from being displaced in two directions. Shown in FIG. 12 is across-sectional view of a main conduit 20 having two opposed engagementcuffs 78. The cuffs 78 are configured in a linear state as shown in FIG.2 and FIG. 3 . The cuffs 78 are configured to engage attachment portions36 of a secondary conduit 26. The engagement of the attachment portions36 to the cuffs 78 inhibit or prevent dislodgement of the secondaryconduit in the two directions shown by arrows 38 and 80.

Secondary conduits can also incorporate attachment portions in the formof bi-directional cuffs that inhibit or prevent dislodgement in twodirections. Shown in FIG. 13, is a secondary conduit 26 havingbi-directional cuffs 82. The bi-directional cuffs 82 are configured toengage opposed main conduit cuffs as shown in FIG. 12.

In some surgical procedures it is desirable to have a side-branchedendovascular device, particularly for the repair of a vessel that is inclose proximity to branched vasculature.

FIG. 14 is a perspective view of an alternate main conduit 50 having afirst open end 22 and a second open end 24. Within the main conduit 50is an internal channel 54 having a first open end 56 and a second openend 58 that is aligned to an opening 60 in the main conduit wall 25.Such a main conduit can be fabricated according to the teaching in U.S.Pat. No. 6,645,242 to Quinn. A secondary conduit 26 having a first openend 27, a second open end 29, a wall 31, and an attachment portion 36 ina deployed state is shown inserted into the internal channel 54. Thesecondary conduit 26 is shown exiting out through the second open end 58of the internal channel 54 and through the opening 60 in the mainconduit wall. The attachment portion 36 is configured to engage and/orinterlock onto the first open end 56 of the internal channel. Thisinterlocking may prevent the dislodgement of the secondary conduit 26along the direction depicted by arrow 38. Forces exerted by the flow ofblood may encourage or drive the attachment portion 36 into full contactwith the first open end 56 of the internal channel 54.

Stents can have various configurations as known in the art and can befabricated, for example, from cut tubes, wound wires (or ribbons) orflat patterned sheets rolled into a tubular form. Stents can be formedfrom metallic, polymeric or natural materials and can compriseconventional medical grade materials such as nylon, polyacrylamide,polycarbonate, polyethylene, polyformaldehyde, polymethylmethacrylate,polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene,polyvinylchloride, polyurethane, elastomeric organosilicon polymers;metals such as stainless steels, cobalt-chromium alloys and nitinol andbiologically derived materials such as bovine arteries/veins,pericardium and collagen. Stents can also comprise bioresorbablematerials such as poly(amino acids), poly(anhydrides),poly(caprolactones), poly(lactic/glycolic acid) polymers,poly(hydroxybutyrates) and poly(orthoesters).

Grafts can have various configurations as known in the art and can befabricated, for example, from tubes, sheets or films formed into tubularshapes, woven or knitted fibers or ribbons or combinations thereof.Graft materials can include conventional medical grade materials such asnylon, polyester, polyethylene, polypropylene, polytetrafluoroethylene(including expanded polytetrafluoroethylene (“ePTFE”)),polyvinylchloride, polyurethane and elastomeric organosilicon polymers.

Stents can be used alone or in combination with graft materials. Stentscan be configured on the external or internal surface of a graft or maybe incorporated into the internal wall structure of a graft. Moreover,main and secondary conduits can incorporate various stent or supportstructures. For example as shown in FIG. 15A, a main conduit 20 maycomprise separate stent segments 90A and 92A, positioned at or near thefirst and second open ends 22 and 24 of the main conduit 20. Similarlythe stent segments 90A and 92A can comprise a single stent 94A extendingfrom the first open end 22 to the second open end 24 of the main conduit20.

Shown in FIGS. 16A and 16B are secondary conduits 26 tailored to beinserted into main conduits 22 along direction arrows 96. As shown inFIG. 16A, a secondary conduit 26 can incorporate stents 90B and 92B ator near the first and second open ends 27 and 29 of the secondaryconduit 26. Similarly the stent segments 90B and 92B can comprise asingle stent 94B extending from the first open end 27 to the second openend 29 of the secondary conduit 26.

Expandable conduits according to the invention can be delivered in aconstrained state endoluminally by various catheter based proceduresknown in the art. For example self-expanding endoluminal devices can beloaded onto the distal end of a catheter, compressed and maintained in aconstrained state by an external sheath. The sheath can be folded toform a tube positioned external to the compressed device. The sheathedges can be sewn together with a deployment cord that forms a “chainstitch”. Once the constrained device is positioned at a target sitewithin a vessel the device can be deployed. In the deployed state, thedevice may still be constrained by the vasculature or by another device.For example a device may assume a diameter of 20 mm when fullyun-constrained. This same device may be deployed into a vessel (or otherdevice) having a lumen diameter of 15 mm and would therefore be“constrained” in the deployed state. An “un-constrained state” cantherefore be defined as the state assumed by the device when there areno external forces inhibiting the full expansion of the device. A“constrained state” can therefore be defined as the state assumed by thedevice in the presence of external forces that inhibit the fullexpansion of the device. The deployed state can be defined as the stateassumed by the device when expanded into a vessel or other device.

To release and deploy the constrained device, one end of the deploymentcord can be pulled to disrupt the chain stitch, allowing the sheathedges to separate and release the constrained device. Constrainingsheaths and deployment cord stitching can be configured to release aself-expanding device in several ways. For example a constraining sheathmay release a device starting from the proximal device end, terminatingat the distal device end. In other configurations the device may bereleased starting from the distal end. Self expanding devices may alsobe released from the device center as the sheath disrupts towards thedistal and proximal device ends. Details relating to constraining sheathmaterials, sheath methods of manufacture and main body compressiontechniques can be found in U.S. Pat. No. 6,352,561 to Leopold et al.,and U.S. Pat. No. 6,551,350 Thornton et al.

In the deployment of a secondary conduit for example, the secondaryconduit can be released from a constraining sheath starting at theproximal (or hub) end of the constrained conduit. In typical procedures,the attachment portion of the secondary conduit is located about theproximal end of the conduit and in an aspect of the invention thisproximal end is the first end released from a constraining sheath, thusalso deploying the attachment portion.

While particular embodiments of the present invention have beenillustrated and described above, the present invention should not belimited to such particular illustrations and descriptions. It should beapparent that changes and modifications may be incorporated and embodiedas part of the present invention within the scope of the followingclaims.

We claim:
 1. A prosthetic conduit system comprising: an expandable mainconduit having a first open end, a second open end, a main conduit wallextending between the first open end and the second open end, an outerconduit surface, and an inner conduit surface having at least oneprotuberance extending therefrom; and an expandable secondary conduithaving at least a portion thereof disposed inside the main conduit, thesecondary conduit extending along an axis between a first open end andan opposite second open end, a secondary conduit wall extending betweenthe first open end and second open end of the secondary conduit andhaving an outer conduit surface, and an attachment portion extendinggenerally outwardly from the secondary conduit wall at an angle of lessthan 90 degrees relative to the outer conduit surface of the secondaryconduit wall when in a deployed state and engaging the at least oneprotuberance of the main conduit to constrain axial displacement of thesecondary conduit relative to the main conduit.
 2. The prostheticconduit system of claim 1, wherein the expandable main conduit includesan opening through the main conduit wall.
 3. The prosthetic conduitsystem of claim 2, wherein at least a portion of the expandablesecondary conduit extends outwardly relative to the outer conduitsurface of the main conduit through the opening in the wall of the mainconduit.
 4. The prosthetic conduit system of claim 1, wherein an innersurface of the at least one protuberance extends at an angle of lessthan 90 degrees relative to the inner conduit surface of the mainconduit wall and engages the attachment portion to constrain axialdisplacement of the secondary conduit relative to the main conduit. 5.The prosthetic conduit system of claim 4, wherein the attachment portionof the secondary conduit engages the at least one protuberance of themain conduit when the secondary conduit is in a deployed state andconstrains axial displacement of the secondary conduit relative to themain conduit.
 6. The prosthetic conduit system of claim 4, wherein theexpandable main conduit comprises at least one opening in the wall andthe at least one protuberance is located adjacent the at least oneopening in the wall.
 7. The prosthetic conduit system of claim 6,wherein the attachment portion of the secondary conduit engages the atleast one protuberance of the main conduit when the secondary conduit isin a deployed state and constrains axial displacement of the secondaryconduit relative to the main conduit.
 8. The prosthetic conduit systemof claim 2, wherein the at least one protuberance comprises an internalchannel having a first open end located within the main conduit and asecond open end at the opening in the wall.
 9. The prosthetic conduitsystem of claim 8, wherein the expandable secondary conduit extendsthrough the internal channel of the main conduit.
 10. The prostheticconduit system of claim 9, wherein the attachment portion of thesecondary conduit engages the first open end of the internal channel ofthe main conduit and constrains axial displacement of the secondaryconduit relative to the main conduit.
 11. The prosthetic conduit systemof claim 1, wherein the expandable main conduit is balloon expandable.12. The prosthetic conduit system of claim 1, wherein the expandablemain conduit is self-expanding.
 13. The prosthetic conduit system ofclaim 12, wherein the expandable secondary conduit is self-expanding.14. The prosthetic conduit system of claim 1, wherein the at least oneprotuberance is selected from the group consisting of barbs, cuffs,hooks, flanges, stent apices and rings.
 15. The prosthetic conduitsystem of claim 1, wherein the expandable main conduit comprises a graftmaterial.
 16. The prosthetic conduit system of claim 1, wherein theexpandable secondary conduit comprises a graft material.
 17. Theprosthetic conduit system of claim 15, wherein the graft materialcomprises ePTFE.
 18. The prosthetic conduit system of claim 16, whereinthe graft material comprises ePTFE.
 19. The prosthetic conduit system ofclaim 1, wherein the expandable main conduit comprises a first stentsegment at the first open end and a second stent segment at the secondopen end.
 20. The prosthetic conduit system of claim 19, wherein thefirst stent segment and the second stent segment comprise a single stentextending from the first open end to the second open end.
 21. Theprosthetic conduit system of claim 1, wherein the attachment portion isselected from the group consisting of barbs, hooks, flanges, stentapices and rings.
 22. The prosthetic conduit system of claim 19, whereinthe first stent segment and the second stent segment comprise nitinol.23. The prosthetic conduit system of claim 1, wherein the expandablesecondary conduit comprises a first stent segment at the first open endand a second stent segment at the second open end.
 24. The prostheticconduit system of claim 23, wherein the first stent segment and thesecond stent segment comprise a single stent extending from the firstopen end to the second open end.
 25. The prosthetic conduit system ofclaim 23, wherein at least one of the first stent segment and the secondstent segment comprises nitinol.